Hi friends!!!
In our previous blog, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.
Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 Technical Documentation.
Let’s discuss in detail about Technical Documentation.
TECHNICAL DOCUMENTATION
In EU MDR 2017/745, the Annex II explains about Technical Documentation. The Technical Documentation structure in EU MDR 2017/745 has following six sections.
1. Device description and
specification, including variants and accessories
2. Information to be
supplied by the manufacturer.
3. Design and
Manufacturing information.
4. General safety and
performance requirements.
5. Benefit-risk analysis
and risk management.
6. Product verification
and validation.
Let’s discuss in detail
about each section.
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1. DEVICE DESCRIPTION AND SPECIFICATION,
INCLUDING VARIANTS AND ACCESSORIES
1.1. Device description
and specification
The product or trade name
and a general description of the device including its intended purpose and
intended users.
The Basic UDI-DI as
referred to in Part C of Annex VI assigned by the manufacturer to the device in
question.
The intended patient
population and medical conditions to be diagnosed, treated and/or monitored and
other considerations such as patient selection criteria, indications,
contra-indications, warnings.
The principles of operation
of the device and its mode of action, scientifically demonstrated if necessary.
The rationale for the
qualification of the product as a device.
The risk class of the
device and the justification for the classification rule(s) applied in
accordance with Annex VIII.
An explanation of any
novel features.
A description of the
accessories for a device, other devices and other products that are not
devices, which are intended to be used in combination with the device.
A description or complete
list of the various configurations/variants of the device that are intended to
be made available on the market.
A general description of
the key functional elements, e.g. its parts/components (including software if
appropriate), its formulation, its composition, its functionality and, where
relevant, its qualitative and quantitative composition. Where appropriate, this
shall include labelled pictorial representations (e.g. diagrams, photographs,
and drawings), clearly indicating key parts/components, including sufficient explanation
to understand the drawings and diagrams.
A description of the raw
materials incorporated into key functional elements and those making either
direct contact with the human body or indirect contact with the body, e.g.,
during extracorporeal circulation of body fluids
The technical
specifications, such as features, dimensions and performance attributes, of the
device and any variants/configurations and accessories that would typically
appear in the product specification made available to the user, for example in
brochures, catalogues and similar publications.
1.2. Reference to
previous and similar generations of the device
An overview of the
previous generation or generations of the device produced by the manufacturer,
where such devices exist.
An overview of identified
similar devices available on the Union or international markets, where such
devices exist.
2. INFORMATION TO BE SUPPLIED BY THE
MANUFACTURER
The label or labels on
the device and on its packaging, such as single unit packaging, sales
packaging, transport packaging in case of specific management conditions, in
the languages accepted in the Member States where the device is envisaged to be
sold.
The instructions for use
in the languages accepted in the Member States where the device is envisaged to
be sold.
3. DESIGN AND MANUFACTURING INFORMATION
Information to allow the
design stages applied to the device to be understood.
Complete information and
specifications, including the manufacturing processes and their validation, their
adjuvants, the continuous monitoring and the final product testing. Data shall
be fully included in the technical documentation.
Identification of all
sites, including suppliers and sub-contractors, where design and manufacturing
activities are performed.
Let's continue with remaining sections in our next blog.
Now I hope you have acquired some knowledge about EU MDR 2017/745 Technical Documentation. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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